A study to assess the effect after video assisted shoulder ligament surgery

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/10/046852
• Lead Sponsor: Healthium Medtech Limited

Brief Summary

The current retrospective study is aimed to assess the safety, efficacy, and functional outcomes of Sironix arthroscopic implants in patients who have undergone Rotator Cuff Tear (RCT)  repair.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-31
• Last Update Posted: 2023-10-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients aged ≥18 years who has undergone rotator cuff repair surgery with Ceptre® Titanium Screw Anchor between January 2019 to July 2022.
• Patients willing to give written consent for the study during an in-clinic visit or providing verbal consent for participation during a telephonic visit.

Exclusion Criteria

• Patients who suffered from traumatic injury to the operated shoulder after surgery.
• Patients who cannot be contacted after three attempts.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the functional outcomes after Rotator Cuff Repair with Ceptre® Titanium Screw Anchor	At baseline

Secondary Outcome Measures

Name	Time	Method
1. To review the safety of Ceptre® Titanium Screw Anchor by evaluating adverse events after surgery.	2. To review the efficacy of Ceptre® Titanium Screw Anchor after Rotator Cuff Repair.

Trial Locations

Locations (1)

EPIC Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

EPIC Hospital

🇮🇳Ahmadabad, GUJARAT, India

Dr Karnav Arvind Panchal

Principal investigator

9879010009

karnav1985@yahoo.com